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COMPLETED
NCT07154147
PHASE4

Oral vs IV Sedation for Cataract Surgery in Older Adults

Sponsor: University of California, San Francisco

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to evaluate the feasibility of comparing oral sedation (a pill) with intravenous (IV) sedation for cataract surgery in older adults. Investigators will assess the feasibility, completeness, and distribution of data related to postoperative recovery, including thinking and memory, as well as participant satisfaction with care. Participants will be randomly assigned to receive either oral sedation with an IV placebo or IV sedation with an oral placebo before cataract surgery. Participants will complete brief surveys assessing recovery before and after surgery and will be contacted by phone after surgery to assess postoperative recovery. Results from this pilot study will inform the design of a future, fully powered trial evaluating sedation approaches for cataract surgery.

Official title: Cataract Oral vs IV Sedation Pilot RCT: A Non-inferiority Assessment of Perioperative Safety and Cognitive Recovery in Older Adults

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2025-08-12

Completion Date

2026-01-19

Last Updated

2026-04-27

Healthy Volunteers

No

Interventions

DRUG

Alprazolam

Participants will take oral alprazolam 0.5 mg 15 to 90 minutes before surgery to promote relaxation and reduce anxiety. An IV placebo (normal saline) will be administered to maintain blinding.

DRUG

Midazolam

Participants will receive IV midazolam 1 mg immediately before surgery to promote relaxation and reduce anxiety. An oral placebo pill will be used to maintain blinding.

Locations (1)

UCSF Wayne and Gladys Valley Center for Vision, Mission Bay

San Francisco, California, United States